The invention relates to the field of implant able breast prostheses, and in particular, filler materials for breast prostheses. Breast cancer has effected over 30 million women in the last 50 years. Recently, there has been a tremendous amount of research in developing breast prostheses which have minimal side effects on the human body even if the outer shell or envelope should rupture causing the filler to seep into other parts of the body. The silicon filled breast envelope has been the leading contributor to the disastrous paranoia in the field.
Saline solution has been determined to be the safest of filler materials. Unfortunately, saline solution produces an unnatural feel and look to the implant. The saline solution further has a low resistance to differences in pressure and drains gradually in about 10 years. The saline solution that enters the body has no adverse effects on the body. In addition, saline implants interfere with mammography of the breast, an important tool for detecting breast cancer.
In response to the failures of saline and silicon envelopes, there have been a number of attempts to make a prosthesis filled with organic filler that fulfilled the aesthetic characteristics provided by silicon solution yet gave the user the safe secure feeling provided by saline solution. The public reaction to the problems caused by silicon implants has generated a number of new implants directed to a safe filler material.
The patent to Destonet U.S. Pat. No. 4,995,882 introduced a breast prosthesis having a filler of peanut oil, sunflower seed oil, or any other material having an effective atomic number of 5.9 which is the atomic number of fat. The purpose of the filler is to permit the use of mammography in detecting tumors in patients having breast implants.
Other attempts to provide a safe filler material include cellulose gelling agents, collagen, starch and even honey. For example, U.S. Pat. No. 5,500,017 discloses a breast implant device using honey as a filler material. Brety, more particularly, discloses that high viscosity syrups used in breast implants hold their shape better and interfere less with mammography. In the event that the envelope used in the Brety implant should break, there are no studies on the effects of syrup inside the body. Moreover, the effective viscosity of the oil used in Destonet et al. or Brety fails to provide an implant that duplicates the natural breast.